BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3132186 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03330
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DISLODGEMENT WAS CONFIRMED. THE FAILURE TO ADVANCE/CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE AND CINE REVIEW, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: ALTHOUGH THE SAFETY AND EFFECTIVENESS OF TREATING MORE THAN ONE LESION PER CORONARY ARTERY WITH XIENCE XPEDITION STENTS HAVE NOT BEEN ESTABLISHED, IF THIS IS PERFORMED, PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS. IN THIS CASE, THE IFU DEVIATION APPEARS TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE DISTAL 1ST OBTUSE MARGINAL (OM1) WITH MODERATE CALCIFICATION. A 4.0 X 12 NON-ABBOTT STENT WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX). THEN, THE 2.25 X 15 MM XIENCE XPEDITION STENT WAS ATTEMPTED TO BE CROSSED THROUGH THE NON-ABBOTT STENT PLACED IN THE SAME PROCEDURE. DURING THE CROSSING ATTEMPT, THE XIENCE XPEDITION STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) BALLOON. AN ATTEMPT WAS MADE TO SNARE THE DISLODGED STENT; HOWEVER IT WAS UNSUCCESSFUL. THE DISLODGED STENT WAS COMPRESSED INTO THE VESSEL AT THE CX/OM1 OSTIUM, USING AN ADDITIONAL BALLOON. A 2.25 X 12 MM NON-ABBOTT STENT WAS THEN IMPLANTED IN THE LESION IN THE DISTAL OM1 TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT SEQUELA WAS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235802 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3010341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: 4.0 X 12 MM PROMUS ELEMENT